FDA 510(k)

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K-번호: K162659 · 2017-06-16

결정일2017-06-16

제품 코드GEX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

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기기 요약

Diode Laser Hair Removal System is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Huamei Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-06-16 under 510(k) number K162659. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Diode Laser Hair Removal System?

Diode Laser Hair Removal System is a medical device that received FDA 510(k) clearance on 2017-06-16. The listed applicant is Shandong Huamei Technology Co., Ltd.. The 510(k) number is K162659.

When did Diode Laser Hair Removal System receive FDA 510(k) clearance?

Diode Laser Hair Removal System received FDA 510(k) clearance on 2017-06-16, under 510(k) number K162659.

Who is the listed applicant for Diode Laser Hair Removal System?

The FDA 510(k) record lists Shandong Huamei Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode Laser Hair Removal System?

The FDA product code for Diode Laser Hair Removal System is GEX. This falls under the Gastroenterology category.

Shandong Huamei Technology Co., Ltd.를 신청인으로 등재한 기타 기록

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